Precision Medicine Group · 10 hours ago
Safety Specialist II
Remote, United States
Full-time
Remote
Mid Level
$72K/yr - $109K/yr
3+ years exp
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Responsibilities
Interfacing with sponsors, vendors, and other internal team members related to drug safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.
Participate in the assessment and set-up of a safety database to capture SAE data.
Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
Preparation and/or review of project‑specific safety reporting plans and medical coding plans.
Preparation and/or review of safety training materials.
Review and/or draft standard operating procedures and work instructions.
Mentor or train new PV staff
May participate (support, review, draft, provide input, etc.) in strategic department development initiatives.
Perform other duties as assigned.
Qualification
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Required
4-year college degree, or equivalent experience ideally in Pharmacy, Nursing, scientific or healthcare discipline
3-5 years clinical trial, PV/Drug Safety experience
Working knowledge of GCP/ICH guidelines and the clinical development process
Health care professional (i.e., RN, BSN, MD, PharmD)
Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation.
Proficient MedDRA and WHO Drug coding
Applies advanced knowledge of the organization, process and structure of clinical studies, PV systems and processes.
Ability to oversee, manage, and resolve higher level, complex problems and prioritize workload to meet timelines with some support from management.
Good understanding of technical and content knowledge
Anticipates case processing needs, identifies, and communicates timelines.
Responsible for case processing on a broad range of clinical studies under the minimal direction of a Safety Lead or other Safety Management
Advanced knowledge and understanding of Global safety regulations, MedDRA, WHO Drug, and GCP and ICH guidelines.
Applies more in-depth knowledge of Argus Safety Database.
Organizes work and priorities effectively with minimal oversight; understand hierarchy of responsibilities.
Manages timelines, communicate flow and deliverables, and monitor progress.
Solid knowledge and understanding of FDA safety regulations, EMA, MedDRA, WHO Drug, MHRA and other ICH guidelines, and global safety regulations.
Solid understanding of clinical trials methodology
Ability to work collaboratively with others but exhibits self-motivation and able to work independently.
May resolve Safety related issues and prioritize workload to meet timelines with minimal support from management.
May work on multiple complex clinical studies and Safety activities.
Solves complex problems using knowledge/skills, precedents and practices.
Exercises independent judgment within broadly defined practices in selecting approaches and methods for obtaining results.
Seeks support for some challenges and problems and proposed solutions.
Recognizes appropriate issues for escalation.
Able to apply advanced Safety Database troubleshooting skills and abilities.
Demonstrates good judgment in selecting approaches, processes, and techniques for obtaining solutions.
Strong knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.
Preferred
Oncology and Rare Disease experience
Industry experience in CRO and/or pharmaceutical company preferred.
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
Founded in 2012Bethesda, Maryland, USA
1,001-5,000 employees
H1B Sponsorship
Precision Medicine Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (2)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase
